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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00547 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PROS0077 | Other Identifier | OnCore | |
| IRB-40373 | Other Identifier | Stanford IRB |
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This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.
PRIMARY OBJECTIVES:
I. To evaluate 68Ga-RM2 PET/CT for detection of intermediate and high-risk prostate cancer prior to prostatectomy.
OUTLINE:
Patients receive 68Ga-RM2 intravenously (IV). Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.
After completion of study, patients are followed up at 24-48 hours and within 3-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (68Ga-RM2 PET/CT) | Experimental | Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy | week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET | True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Osseous and Distant Metastatic Lesions | Up to 3 years | |
| Maximum Standardized Uptake Value (SUVmax) From 68Ga-RM2 PET | Correlation between SUVmax from gallium Ga 68-labeled GRPR antagonist BAY86-7548 PET and short axis diameter of nodal disease on cross sectional imaging correlate to presence of true pathology will be performed. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru | Stanford Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37555901 | Derived | Duan H, Davidzon GA, Moradi F, Liang T, Song H, Iagaru A. Modified PROMISE criteria for standardized interpretation of gastrin-releasing peptide receptor (GRPR)-targeted PET. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):4087-4095. doi: 10.1007/s00259-023-06385-z. Epub 2023 Aug 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (68Ga-RM2 PET/CT) | Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician. Computed Tomography: Undergo PET/CT Gallium Ga 68-labeled GRPR Antagonist BAY86-7548: Given IV Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo PET/CT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2021 |
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| Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 | Drug | Given IV |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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| week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess |
| Up to 3 years |
| PSA Progression Free Survival | Patients with and without pelvic nodal metastases will be compared. | At 1 year |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (68Ga-RM2 PET/CT) | Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician. Computed Tomography: Undergo PET/CT Gallium Ga 68-labeled GRPR Antagonist BAY86-7548: Given IV Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo PET/CT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | participant |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy | Posted | Number | 95% Confidence Interval | percentage of cases | week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess |
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| Secondary | Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET | True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy | Posted | Number | 95% Confidence Interval | percentage of cases | week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess |
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| Other Pre-specified | Incidence of Osseous and Distant Metastatic Lesions | Not Posted | Up to 3 years | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximum Standardized Uptake Value (SUVmax) From 68Ga-RM2 PET | Correlation between SUVmax from gallium Ga 68-labeled GRPR antagonist BAY86-7548 PET and short axis diameter of nodal disease on cross sectional imaging correlate to presence of true pathology will be performed. | Not Posted | Up to 3 years | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | PSA Progression Free Survival | Patients with and without pelvic nodal metastases will be compared. | Not Posted | At 1 year | Participants |
10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (68Ga-RM2 PET/CT) | Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician. Computed Tomography: Undergo PET/CT Gallium Ga 68-labeled GRPR Antagonist BAY86-7548: Given IV Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo PET/CT | 0 | 44 | 0 | 44 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David G Marcellus | Stanford Medicine at Stanford University | 650-723-4547 | dmarcel2@stanford.edu |
| May 22, 2023 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| C582579 | BAY 86-7548 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
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| Negative predictive value |
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